Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)

NCT05226585 | Completed

• 1 other identifier: 2107024013
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the mechanisms of change in Cognitive Behavioral Therapy for insomnia (CBTi) in a sample of adults aged 50-65. This study aims to evaluate the pre-post treatment change in sleep, circadian rhythms, biomarkers, cognitive performance, and structural and functional magnetic resonance imaging scans (MRI).

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

insomnia; insomnia disorder; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (3)

• Insomnia Severity Index

  Self-reported severity of insomnia symptoms is assessed once at baseline.

  Pre-treatment

• Insomnia Severity Index

  Self-reported severity of insomnia symptoms is assessed weekly through the duration of treatment.

  During treatment

• Insomnia Severity Index

  Self-reported severity of insomnia symptoms is assessed once at posttreatment.

  12-week Post-treatment

Secondary Outcomes (3)

• Diary-assessed Sleep

  Pre-treatment

• Diary-assessed Sleep

  During treatment

• Diary-assessed Sleep

  12 week Post-treatment

Other Outcomes (10)

• Circadian Rhythm

  Pre-treatment

• Circadian Rhythm

  12 week Post-treatment

• Magnetic resonance imaging (MRI)

  Pre-treatment

Study Arms (4)

In-person CBTi

ACTIVE COMPARATOR

CBTi of variable treatment length will be administered by trained study staff in-person.

Behavioral: In-Person Cognitive Behavioral Therapy for Insomnia

Telehealth CBTi

ACTIVE COMPARATOR

CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference.

Behavioral: Telehealth Cognitive Behavioral Therapy for Insomnia

Internet CBTi

ACTIVE COMPARATOR

Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi).

Behavioral: Internet Cognitive Behavioral Therapy for Insomnia

Waitlist Control

NO INTERVENTION

Treatment will be postponed by 12 weeks.

Interventions

In-Person Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

Cognitive behavioral therapy is recommended as a first-line treatment for insomnia (CBTi). CBTi contains the following well-validated components of cognitive behavioral treatment for insomnia: stimulus control, sleep compression, sleep hygiene, relaxation training, and cognitive restructuring.

Also known as: CBTi

In-person CBTi

Telehealth Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

Telehealth cognitive behavioral therapy is recommended as a first-line treatment for insomnia (CBTi) conducted via audio-video communication. tCBTi contains the following well-validated components of cognitive-behavioral treatment for insomnia: stimulus control, sleep compression, sleep hygiene, relaxation training, and cognitive restructuring.

Also known as: tCBTi

Telehealth CBTi

Internet Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

Sleep Healthy Using The Internet (SHUTi; aka iCBTi) is a self-guided, fully automated, online CBTi program that includes interactive features: personalized goal setting, graphical feedback based on inputted data, animations/illustrations to enhance comprehension, patient vignettes, and video-based expert explanations.

Also known as: iCBTi

Internet CBTi

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50-65
• Normal hearing with or without hearing aids
• Ability to speak and read English and ability to give informed consent
• Possession of a computer with video and audio capabilities
• Meets DSM-5 Criteria for Insomnia Disorder
• Internet speed sufficient for participating in teletherapy (e.g., Zoom Health) or SHUTi (for iCBTi group)
• MoCA scores ≥24 will be deemed normal cognitive status and considered eligible for study participation and/or assessed by the ability to comprehend the baseline screening questionnaires
• Willing to refrain from new external behavioral health or medication treatment for issues pertaining to sleep during participation in the study
• Indication that the individual plans to be in the area for the 6 months following the first baseline assessment

You may not qualify if:

• Current circadian rhythm disorder, sleep deprivation, or hypersomnia and related sleep disorders (assessed with clinical interview and/or self-report) as CBTi has not been validated in these populations. Verified by self-report and/or clinical interview (SCISD-R)
• Untreated sleep disordered breathing (e.g., obstructive sleep apnea) assessed by self-report, clinical interview, and/or diagnostic sleep study (i.e., baseline sleep study PSG)
• Fear/phobia of needles (conflict with blood draw) and/or small spaces (conflict with MRI scanner)
• Current suicide risk meriting crisis intervention as assessed by the Patient Health Questionnaire (PHQ-9) and/or disclosure of serious suicidal ideation
• Pregnancy (self-report, proposed instruments and treatments have not been validated in this population)
• Sleep efficiency \> 85%, assessed by the sleep diary
• Serious mental health diagnosis (e.g., bipolar disorder or psychosis) assessed by structured interview (M.I.N.I.)
• Currently engaged in evidence-based psychotherapy for Insomnia (i.e., Cognitive Behavioral Therapy) by self-report
• Failure to follow protocol (e.g., consistent "no show" for appointments, answering questionnaires dishonestly, refusal to complete more than 2 assessments \[e.g., fMRI and Neuropsych\])

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

The University of Arizona

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Daniel J Taylor, Ph.D.

  The University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and outcomes assessor will not be aware of participant study conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three treatment arms and a waitlist control

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: February 7, 2022
• Study Start: September 26, 2021
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: April 16, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)